The present invention relates to tubes for medical applications and more particularly, to a nasal intubation device for penetrating and irrigating the ethmoid sinus region.
Intubation devices, in general, are well known in the medical field. Tubes are often inserted into body passageways or cavities of a patient to ventilate, drain, and/or irrigate the cavity into which the tube in inserted. Continuing efforts are being made to design intubation devices that are easily and comfortably inserted into a patient, particularly when the tube must be left in place within the patient.
One medical use for an intubation device is in the treatment of chronic rhinosinusitis (CRS). CRS is a disease of the nasal and paranasal sinuses characterized by the symptoms of facial pain, nasal obstruction, and rhinorrhea. Dysfunction of the anterior ethmoidal cells is the main cause of chronic sinusitis. The ethmoid sinus is a complex labyrinth formed by independent cells. Under normal conditions, narrow spaces such as fissures and ostia are very resistant to infection. When corresponding mucosal areas are firmly pressed together, however, secretions cannot be eliminated by ciliary transport, providing ideal conditions for viral and bacterial growth.
When recurrent infection and clinical symptoms are not improved by medical therapy, surgery may be performed involving the removal of ethmoidal tissue and middle meatus antrostomy. The current surgical intervention that is recommended in these patients is functional endoscopic sinus surgery (FESS). This procedure is a drainage procedure that exteriorizes the ethmoid labyrinth into the superior nasal vault and opens the fronto nasal canal and maxillary ostium for drainage. This procedure removes the natural structure for the ethmoid to control the mucosal hypertrophy that is actually causing the persistence of symptoms.
However, some patients (e.g., 50% of allergic subjects) with diffuse disease do not benefit from the surgical procedures and exhibit persistent mucosal disease, which leads to repetitive antibiotic treatment and even surgical revisions. Surgical intervention, which increases exposure of the maxillary sinus mucosa to environmental air, may serve to increase mucosal inflammation and the need for surgical revision. Topical corticosteroid treatment has been used for reducing inflammation and ameliorating the symptoms of allergic rhinitis but has been less successful in patients with CRS. Intubation and irrigation of the maxillary cavity has been performed successfully, but existing intubation devices have been unable to effectively penetrate the ethmoidal sinus region to allow direct treatment of the ethmoidal sinus cells.
Accordingly, an intubation device and system is needed to treat chronic sinusitis or other similar conditions by penetrating the ethmoidal sinus region and by irrigation of the ethmoidal cells with medication without substantial disruption of the natural anatomy.
The present invention features a nasal intubation device comprising a flexible tube having a proximal end, a distal end, and a passageway extending from the proximal end to the distal end. A distal tip is located at the distal end of the flexible tube and includes a pointed end and flanges extending toward the proximal end of the flexible tube and at an angle with respect to the flexible tube. In one example, the flanges form an angle of about 30xc2x0 with respect to the flexible tube. The flexible tube preferably includes a perforated area proximate the distal end, which communicates with the passageway. A support member, such as a ring, can be positioned around the distal end of the flexible and beneath the flanges. The width of the flanges preferably tapers outwardly away from the pointed end.
The present invention also features a nasal intubation system comprising an implantation device including a proximal end, a distal end, and a passageway extending from the proximal end to the distal end. The implantation device preferably has a bend proximate the distal end. The nasal intubation device is positioned within the passageway for insertion within the nasal passageway. The support member is capable of supporting the nasal intubation device on the distal end.